Modified T-Stenting With Szabo Technique Versus T-Stenting for Bifurcation Lesions in Coronary Heart Diseases

Not Applicable

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT03714802
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

The study will compare clinical outcomes of modified T-stenting with Szabo technique with T-stenting for bifurcation lesions in coronary heart diseases.

Detailed Description

Accurate deployment of stents in ostial lesions is difficult with traditional angiographic guidance. Szabo technique, which used a second angioplasty guide wire to anchor the stent by passing the proximal end of the anchor wire through the last cell of the stent, demonstrated accurate placement of the stents in ostial locations. In bifurcation lesions, 2-stent strategy positioning with Szabo technique was not investigated. Modified T-stenting with Szabo technique may improve prognosis of bifurcation lesions through reducing stents overlap. There is no clinical trial focuses on the effect and outcome of Szabo technique for coronary artery bifurcation lesions in contrast with conventional strategy.

In this study, the authors choose the closest 2-stent strategy, T-stenting, as control. We hope to determine whether a planned Szabo 2-stent technique is superior to T-stenting for patients with bifurcation lesions.

Patients with bifurcation lesions will be randomly assigned to receive Szabo 2-stent technique or T-stenting strategy. Clinical outcomes and imaging assessment will be used to estimate their effects.

Study Timeline

• Study First Submitted: 2018-09-21
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-18
• Study First Posted: 2018-10-22
• Study Start: 2019-01-01
• Last Update Submitted: 2019-03-02
• Last Update Posted: 2019-03-05
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient must be at least ≥18 years of age.
• Lesions are eligible for percutaneous coronary intervention (PCI).
• Patient has stable/unstable angina or myocardial infarction (MI).
• Bifurcation lesions (Medina 1,1,1/0,1,1/1,0,1) without left main ostial lesions.
• Downstream lesions could be covered by two stents.
• Diameter of vessel ≥2.25mm
• Diameter stenosis in main vessel and side branch ≥ 50% by visual estimation.

Exclusion Criteria

• Severe tortuosity or calcification affected procedural success.
• Patient was allergic to the study stent or protocol-required concomitant medications.
• Patient is intolerable to dual anti-platelet therapy.
• Patient has any other serious medical illness that may reduce life expectancy to<12 months.
• Patient is a woman who is pregnant or nursing.
• Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.
• Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.
• Coronary restenosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite of cardiac death, nonfatal myocardial infarction and target lesion revascularization	1 year after coronary angiography	record in follow-up

Secondary Outcome Measures

Name	Time	Method
rate of all cause death	30 days and 12 months after primary angiography	Recorded in follow-up
rate of cardiac death rate	30 days and 12 months after primary angiography	Recorded in follow-up
late lumen loss	index procedure and 12 months follow up	Measured through intravenous ultrasound
rate of recurrent myocardial infarction rate	30 days and 12 months after primary angiography	Recorded in follow-up
rate of stent thrombosis	30 days and 12 months after primary angiography	Recorded in follow-up
residual stenosis of side branch	Immediately after stent implantation and 12 months after primary angiography	Measured through angiography
rate of target vessel revascularization rate	30 days and 12 months after primary angiography	Recorded in follow-up
residual stenosis degree	Immediately after stent implantation and 12 months after primary angiography	Measured through intravenous ultrasound

Trial Locations

Locations (2)

Zhongshan Hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai Zhongshan Hospital; 🇨🇳 Shanghai, China